Santreva-ATK Endovascular Revasculariztion Catheter— 510(k) K252315

Substantially Equivalent

AngioSafe, Inc.

FDA 510(k) clearance K252315 for Santreva-ATK Endovascular Revasculariztion Catheter, Substantially Equivalent on 2025-09-22. Applicant: AngioSafe, Inc..

Clearance details

Applicant: AngioSafe, Inc.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2025-07-25
Decision date: 2025-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.